药物类型 单克隆抗体 |
别名 SHR 1918、SHR1918 |
靶点 |
作用方式 抑制剂 |
作用机制 ANGPTL3抑制剂(血管生成素样蛋白-3抑制剂) |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (中国) |
开始日期2025-08-01 |
申办/合作机构 |
开始日期2025-02-13 |
申办/合作机构 |
开始日期2024-07-02 |
申办/合作机构 ![]() [+1] |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
家族性混合型高脂血症 | 临床3期 | 中国 | 2025-09-24 | |
家族性混合型高脂血症 | 临床3期 | 中国 | 2025-09-24 | |
纯合子家族性高胆固醇血症 | 临床3期 | 中国 | 2024-12-30 | |
纯合子家族性高胆固醇血症 | 临床3期 | 中国 | 2024-12-30 | |
II型高脂蛋白血症 | 临床2期 | 中国 | 2023-11-30 | |
II型高脂蛋白血症 | 临床2期 | 中国 | 2023-11-30 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床1期 | serum low-density lipoprotein cholesterol | triglyceride | 72 | 餘選選顧醖選製遞繭蓋(衊餘憲簾廠簾簾構顧鹽) = Treatment-emergent adverse events were comparable between the SHR-1918 (90.7%) and placebo (94.4%) groups. All treatment-emergent adverse events were mild or moderate in severity, with no serious adverse events or treatment-emergent adverse events leading to death 遞遞顧鹹遞觸襯淵願積 (壓艱膚淵鏇壓壓顧鬱糧 ) | 积极 | 2025-06-27 | ||
临床1期 | - | 選築顧觸膚製鬱鹹遞範(簾鏇積構鏇網遞遞襯壓) = 300mg及以上剂量水平的LDL-C降低超过30%,持续64天以上,最高达49.1%。 餘醖構鏇廠蓋築蓋鏇餘 (鏇窪觸願製範觸構構觸 ) 更多 | 积极 | 2024-09-06 | |||
临床1期 | - | - | 夢膚壓糧顧夢顧選選齋(鏇醖淵鹹齋鏇膚艱蓋糧) = Treatment-emergent adverse events (TEAEs) were reported in 49 (90.7%) subjects in the SHR-1918 group and 17 (94.4%) subjects in the placebo group. The most common TEAEs were upper respiratory tract infection (25.9% with SHR-1918 vs. 27.8% with placebo), protein urine present (22.2% vs. 22.2%), and blood uric acid increased (16.7% vs. 16.7%). All TEAEs were mild or moderate in severity. There were no serious adverse events or TEAEs leading to death. 製艱範簾簾遞鬱網餘艱 (襯簾鏇醖構膚鹽構齋範 ) 更多 | - | 2024-09-01 | ||
Placebo |